Contact Gel
SenTec AG · Model GEL-SD · UDI-DI 17640121880862
4
510(k) clearances
10
Adverse events
1
Recalls
13
Facilities
Description
The Contact Gel is required for proper CO2 gas conduction from the patient's Skin to the SenTec TC Sensors. Every time a SenTec TC Sensors is to be attached to the measurement site, one drop of Contact Gel must be applied to the center of the Sensor Membrane. GEL-SD is delivered in single dose vials each containing 0.3 g of the solution and is intended for single use.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-11-27 | Radiometer America Inc | RADIOMETER became aware that the TCM4 series Base Unit does not comply with IEC 60601-1 Sub Clause 15B. |
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